BonjongoKid-🎾ServeBot

@SouthernDrive21 Boyyy, you're quick!! Thanks for all the good works on our behalf!!!

$NWBO 10-Q is out, will be reviewing sec.gov/ix?doc=/Archiv…

@JackNdreu @TomBaxers @METhompson72 Hahahaha...I'm jealous of Mark too lol. Btw, great question to Mark, Tommy.

@TomBaxers @METhompson72 I hate mark already just bc of his timing! lol

$NWBO - Northwest Biotherapeutics I spent 6 months due diligence on this pick, then went large. I have met with all the management and visited the Sawston manufacturing plant twice. I had oncologists and neurologists review their clinical data. I am betting that the tech is real, it’s is transformative, it is applicable to all solid tumours and cancers. I am betting that it will receive regulatory approval. I am betting that the shorts are screwed.

@ElvirPons Huge congratulations to him, mom and dad and entire family. What a beautiful mother's day blessing!!!

Congratulations to my son Dr Michael Pons on his graduation from Rice University. Hooded by his mentor and academic advisor Timothy Morton. So proud and grateful! 👨‍🎓🦉 #RiceGrads2026

@ThomasOwenMcCa1 Our dear friend ... wow!! So thank, so happy, so humbled by this remarkable milestone. T-O-Mc, may you continue to prosper and shine the light of courage and hope to all in this and other medical journeys. You're truly an inspiration. Thanks for sharing with us.

May 6th 2026 was my 50th birthday 🎂! (photo credit my son Jake). It was a huge milestone for me, not only did I celebrate my 11th anniversary of being administered the DCVax in March. I never thought I’d make it to 50, especially celebrating with my family. I’m very grateful to so many people who played a vital role in keeping me here. Dr. Linda Liau, Dr. Timothy Cloughesy, Nanette Fong, My family, my friends, F.O.G. However even though I’m a long tail survivor, I’m sure there are many Doctors still dismissing this scientific breakthrough in personalized immunotherapy. To them I say, the proof is in the pudding, I’m not an anomaly. I’m not a one off… I’m thriving, living my life with gratitude, & grace. I KNOW THAT NWBO’s DCVax WILL BE APPROVED. & there is little any Big Pharma executive or MARKET MAKER ON WALL ST. Can do about it. Sorry Kenneth C. Griffin your greed & political donations won’t save you, a wave 🌊 is coming for you… @kshaughnessy2 @LisainNJUSA @HollensbeAmanda @nprpolitics @NorthwestBio @ElvirPons @NHSEnglandLDN @MHRAgovuk @NYMag @TheLastWord @LastWeekTonight @latimes @LAmag

@2StefanMoore This absolutely tears me to pieces and very personal in so many ways I won't even get into. But suffice to say no child should endure such or any similar traumatic medical situation. Sending love and prayers to Will and his family.

The mother of 15 year old Will Roberts, who is fighting stage 4 #BoneCancer in Alabama, shared an emotional update. In a new video, she shows Will getting his head shaved for the second time. Her words hit hard: “The first time felt like shock… like we were just trying to survive. This time I knew what it really meant. But there he was — same smirk, same fire, laughing while ‘Cutting Carl’ buzzed away.” “Hair doesn’t define him. This chapter still belongs to a warrior.” Praying for you, Will. Keep fighting, Champ. 🙏❤️

@GoneGoodguy @LisainNJUSA I'm beginning to think MHRA already by way if their RFIs and other interactions already indicated approval was guaranteed, but just waiting for a 3rd or 4th leg of some technical requirements to be met. Feeling much better!!

Exactly!!! Go #NWBO $NWBO!!!

@Mionaer1 @KryptyPop It's still beyond me he's (@metacollectiveG) is no more. What a loss!!! RiP 🙏

$NWBO

TWEEPS: Trump votes by mail in every election, yet he's pushing the SAVE Act to end mail-in voting for millions of Americans. If it’s secure enough for him, it’s secure enough for us. I need 1,000 fast RTs and replies using #TrumpVotesByMail. Please and thank you! 🙏💪

@SouthernDrive21 @andrewcaravello And does nwbo mgmt even take advantage of these types of events to showcase their pipeline or they're not allowed to or lack resources? Investors are just exhausted by the continued blackout.

$NWBO Link for public event: videocast.nih.gov/event-calendar…

@RPD60 @smith348572 @Dave46217976 @MHRAgovuk I agree with this likely premise. This approval or non approval will likely define what becomes of the company. That in mind, I'm sure they'd stretch the clock off for RFIs to the max to make sure they get every response right. Still doesn't help the waiting pain though 😕

@smith348572 @Dave46217976 @MHRAgovuk One plausible reason for the long process could be that there was an inordinate amount of “stoppage time” for the company to address questions posed by the MHRA. Would it surprise us that the company was slow in this regard?

$NWBO Dear @MHRAgovuk ,  You have to explain to me how a therapy that: 1Shows no meaningful toxicity or serious side effects, 2Demonstrates 13.5% five-year overall survival versus about 5% with the current standard of care, 3Has GMP manufacturing already approved at the Sawston facility (December 2025), 4Was supported by Phase 3 trial results published in @JAMAOncology, 5Targets a disease where no meaningful new therapy has been approved for glioblastoma in more than 20 years can still remain unapproved after more than two years of regulatory review. My concern is not about the therapy itself. The data exist, the safety profile is clear, and the manufacturing capability has already been authorized. The real concern is the inefficiency and heavy bureaucracy within the MHRA process. $NWBO also has a large and highly engaged community following this application. Many people—patients, families, physicians, and investors—are carefully examining every step of this process and trying to understand why a decision continues to be delayed. Given the circumstances, it is natural that people begin asking what the real reason is for the prolonged delay, especially when there are well-known financial interests that have publicly worked against this company for years. At some point, transparency becomes necessary. @Siobhain_Mc @wesstreeting @Nigel_Farage @Keir_Starmer

@LisainNJUSA @HollensbeAmanda The Angels are sending smiles down from above to you and your family in different ways during these difficult times. This video is just one way. Prayerfully, more to follow 🙏

@HollensbeAmanda This brought such a smile to my broken heart. Keep at it. 💛

Braelyn update Friday 3/13 Today felt like a big step forward. Braelyn was finally able to shower and wash her hair (with help from Mom), and she was very happy to trade hospital pajamas for real clothes again. She’s been eager to walk and even went down 20 stairs today with one railing and minimal assistance from mom. Tonight she will finally transfer to an inpatient rehabilitation facility where she’ll begin intensive therapy to regain strength, speech, and independence. We are especially grateful that this facility will allow Braelyn to continue taking her seizure medications exactly as she has been at home, which is critical for her seizure control. Several of Braelyn’s doctors here at UCLA were surprised and disappointed that another highly ranked rehab facility would not accept her unless we agreed to change the formulation of her seizure medication — something that previously caused a significant increase in seizures. Thankfully, we have now found a place willing to work with Braelyn’s medical needs. We’re grateful to finally move forward with rehab and the hard work of recovery. 🤍

@LisainNJUSA Todd's and your entire family's strength& fighting spirit have combined to inspire &make us better individuals. The love for family & strength Lisa demonstrated throughout this journey will continue to help pull you & entire family throughout this most challenging times. RIP 🙏

$NWBO #DCVAX It is with unbearable sorrow that I share with you that my warrior husband, Todd, was rushed to the ER Saturday with double pneumonia/sepsis. It was too much for his body. After 46 #GBM months, he passed early Sunday, waiting for our son/DIL to return from Italy.🥺

@CscottLawyer @d_stock07734 I was thinking similarly. SMH!!!

@d_stock07734 $NMBO. I see a lot of wishful thinking with Merck. How is this relevant to NWBO?

@alphavestcap Very helpful to read. Frustration at the top. Too many variables also, including howmany RFIs n how long it takes nwbo to respond knowing fully well they have just 1-shot for survival- get the MAA approval which means RFI replies take longer than usual cause tons of clock stops!!

10baggerz. $nwbo @alphavestcap Re: None Friday, February 27, 2026 1:21:33 PM Post# of 816218 Here’s the latest from GZ who was kind enough to reply to me even though I was flaming his email inbox.  On Fri, Feb 27, 2026 at 7:49?AM George Zavoico @nwbio.com> wrote:HI,I’ve been traveling so I’m sorry for not being prompt. But what do you want us to do? You know that no company ever provides shareholders with day to day or week to week updates on operations. We almost immediately inform everyone when a material event occurs. We provided a comprehensive update at the ASM and are making progress on all fronts. We are as frustrated as you,  if not more so, by the long time it is taking the MHRA to review our MAA. The review process is ongoing, so we are being as patient as we can. If the UK Parliament can’t seem to get them to move on this, I don’t think there’s much we can do in that regard.No more travel next week, so happy to arrange a call if you’d like.Cheers, George IMHO it is what it has always been, the MHRA is taking forever and the company is powerless to do anything to speed up the decision. This is of course disappointing, but it isn’t surprising knowing the complexity and trial complications of the treatment, the small size and lack of funding/influence of NWBO, the lack of experience and past delays of management, and the fact that the MHRA is likely controlled by large BPs like Merck who are partly owned by companies NWBO is suing like citadel.  WHAT IS SURPRISING TO ME IS THAT GZ WOULD PUBLICLY EXPRESS EXTREME FRUSTRATION WITH THE MHRA AND EVEN INVOKE THE UK PARLIAMENT BEING UNABLE TO SPEED UP THE PROCESS. IT SURE SEEMS LIKE THE MHRA IS SLOW WALKING THE MAA 🤷🏻‍♂️

@SouthernDrive21 Well, these new jobs all point to management already having significant positive indicators on review outcome. This knowledge only comes at the end stage of the review process. Guessing we're in logistical clean-up phase now folks. As for the wait so far... no words!!

$NWBO More new job postings

@ElvirPons 💯% Doc!!

@d_stock07734 @andrewcaravello @Cred54675419C RFIs RFIs RFIs are killing the clock, IMO. MHRA says they've hitting their metrics, I believe them. nwbo probably got a ton of RFIs which stops the clock, takes good deal of time to respond adequately to each. Novel platform, so expected. Hard to stomach, but what to do but wait?

@justinkeister5 @MonsonVO Justin, gotta give the guy credit for publicly contradicting his boss contrary to what we're used to seeing from the other stooges who go to such hearings and outright lie, or deflect and detract at best. Thank God in this instance, medical research got it's due credit!!

No clinical trial has ever shown a causation link between vaccines and autism.

@ElvirPons Hearty congratulations Doc & Dad of graduate 👏 👏 👏 👏

Proud of my son! Soon to graduate with his PhD from Rice university. 👨‍🎓

@peter_brit Hi Peter Thanks for this note. I'd say though that we've heard similar and even more review bullish talk from the MHRA over and over again. But look at what's happening to the dcvax review which is already in compassionate use. More action, so far all talk.

#dcvax $nwbo #gbm Makary’s priorities: Faster reviews, domestic manufacturing, and AI : 28 January 2026 “We saw with operation Warp Speed we were able to get to a decision quickly. I would like to see the same level of urgency that we saw as a regulatory body with Operation Warp Speed, when people were dying of COVID.” He said that this same approach can apply to diseases across multiple areas, including neurodegenerative diseases, cancer, and other debilitating conditions" US Food and Drug Administration (FDA) Commissioner Marty Makary said he wants to see the same sense of urgency given to Operation Warp Speed applied to the agency’s Commissioner’s National Priority Voucher (CNPV) program. During a fireside chat at the CASSS Well-Characterized Biotechnology Products (WCBP) conference in Washington, DC on Wednesday, Makary also said that FDA plans to designate the first company in its PreCheck program this summer. The CNVP program is “going great,” Makary said. “We’ve got to try new things. We have to try pilot this and see what we can do differently.” Makary likened the voucher program to Operation Warp Speed, the initiative to quickly deliver COVID-19 vaccines during the first Trump administration. “We saw with operation Warp Speed we were able to get to a decision quickly. I would like to see the same level of urgency that we saw as a regulatory body with Operation Warp Speed, when people were dying of COVID.” He said that this same approach can apply to diseases across multiple areas, including neurodegenerative diseases, cancer, and other debilitating conditions. Makary stated that the pilot program is primarily aimed at expediting the reviews of the chemistry, manufacturing, and controls (CMC) portion of submissions while the therapies are being tested in clinical trials. “When clinical trial results are released, it seems inefficient to then revisit aspects of the application that should have been addressed during the interim phases of the Phase 3 clinical trials,” Makary said. Yet there have been concerns raised about the CNPV program, which prioritizes FDA review of drugs deemed critical to national security, both internally at FDA and within industry. The Associated Press recently reported that some FDA officials have raised concerns about the legality and ethics of the program. (RELATED: This Week at FDA: Drug voucher program hits a snag. GOP targets abortion drug, and more, Regulatory Focus 16 January 2026) “We need to challenge the assumption that it takes 10 to 12 years for a new drug to market, and we have to challenge the assumption that manufacturing has to be done outside the United States. We are really suffering from 35 years of globalists squeezing margins by moving manufacturing outside the United States, we are on a mission as part of the America First agenda to bring manufacturing back to the United States,” Makary said. When asked to update workshop participants on the status of the PreCheck program, Makary said there are plans to designate the first company this summer. The program was announced in August 2025 and is intended to streamline the agency's oversight of certain manufacturing facilities based on national priorities, to provide greater regulatory predictability, and to encourage the construction of domestic factories. He added that “companies have to make decisions based on long-term factors in the marketplace and may not know what the climate is going to be like in five years or ten years, so when you have assurance that you will get manning going in the us quickly.” Simon Hotchin, vice president of regulatory affairs at Amgen, noted that a common theme from the discussion is the need to front load assessments and asked where else such front loading could be brought to bear. Makary stated that AI can also help expedite reviews and conduct initial processing of applications, which currently takes 60 days. “In the modern era, do we think that making patients wait for an additional 60 days because we have to make sure that the application is complete, where with modern technology and AI we can get that checked on in a day?” Makary also noted that FDA was the first federal agency to roll out an agency-wide AI assistant with the launch of its ELSA tool last year and said that FDA’s scientific reviews “love” ELSA. Makary added that AI and modeling can reduce the need for animal testing. “With animal testing, historically we always assumed that if we give something to a chimpanzee or a bunny rabbit before we give it to humans, we would get an answer as to whether it is dangerous or safe. I mean, we are not writing on stone tablets anymore. We’ve got powerful scientific predictive mathematical modeling. We’ve got computational modeling and AI powered computational modeling where the computer looks at the structure of the molecule and can predict how it will interact with receptors in the body and create a panel of toxicity.” He said that using these modeling tools can shave six to nine months off the drug development timeline. In April 2025, the FDA announced that it was loosening its requirement for animal testing of monoclonal antibodies (mAbs) and other drugs. In its place, FDA will seek to reduce, refine, and replace the animal testing requirement where appropriate using real-world safety data from other countries with comparable regulatory standards as well as with New Approach Methodologies (NAMs) such as artificial intelligence (AI)-based toxicity and cell line computational models and organ-on-a-chip systems. (RELATED: FDA seeks to reduce animal testing requirements for mAbs, other drugs, Regulatory Focus 11 April 2025) Makary also said that FDA is taking further action to adopt AI by updating two FDA guidances to ease its oversight of general wellness devices and clinical decision support (CDS) software. (RELATED: FDA relaxes oversight of general wellness devices, CDS software, Regulatory Focus 7 January 2026) “Basically, the nutshell of that is if it is consumer grade, we are going to get out of the way. You don’t need to come to the FDA … If it's medical grade, and you use this term in your marketing, we are going to want to see a validated data set.” raps.org/news-and-artic…